This post is from the non-Reed Smith side of the blog.
It’s been a bit of a slow news week in the drug and device litigation world. We are coming off a short work week and like the rest of us, judges may be looking to enjoy a few extra hours outdoors during these late spring days. We don’t blame them. While we prefer bringing you hot of the presses news or interesting new takes on old standards, sometimes all we have to report is that good law continues to be good law.
That’s today’s case – another blow to innovator liability. As you’ll see from our innovator liability scorecard, Rafferty v. Merck & Co., 2016 Mass. Super. Lexis 48 (Mass. Super. May 23, 2016) isn’t the first time a Massachusetts court has rejected this concept. But now that it has done so twice, we hope Massachusetts can be added to the list of states where innovator liability is now dead (we won’t say “and buried” since there is no state supreme court ruling yet). The case contains a thoughtful analysis of the issue and is certainly worthy of including if you are briefing this topic.
Plaintiff ingested finasteride, the generic version of Merck’s Proscar. After experiencing complications, plaintiff brought suit against his prescribing physician and Merck. Id. at 1. Plaintiff alleges that even though he didn’t ingest Merck’s product, as the brand manufacturer, Merck “had a duty to maintain the accuracy of the labels for those individuals who would rely on those labels,” including individuals who would ingest generic product. Id. at *8.
The court starts its analysis with the framework for how a generic drug gets FDA approval and following approval how the labeling requirements for brand and generic manufacturers differ. Id. at *3-6. This regulatory framework serves as the cornerstone for the Supreme Court’s Mensing and Bartlett decisions which largely insulate generic drug manufacturers from product liability lawsuits. The Rafferty court, like most others to have considered the issue, recognized the “unfortunate” result of barring generic users from recovery but also like most other courts, it was unwilling to bend or expand existing law to extend product liability to a company that did not manufacture the product at issue.
Under Massachusetts law, a manufacturer has a duty to warn foreseeable users about risks of its own products, not about risks of a product manufactured by another company. Id. at *11. Plaintiff focused on the “foreseeable” aspect of this principle arguing it is foreseeable that an individual who uses a generic drug will receive and rely on the brand label and warnings. Id. at *14. The court found it did not need to decide the foreseeability question, because “whether a defendant owes a plaintiff a duty of reasonable care is [also] decided by reference to existing social values and customs and appropriate social policy.” Id.
One such policy consideration is the relationship between brand and generic drug manufacturers. Brand manufacturers invest the money and resources to develop pioneer drugs while generic manufacturers duplicate successful drugs, a less costly operation. While it may seem unfair to leave generic drug users without a course of action for alleged personal injury, it would be equally unfair to saddle brand manufacturers, who already shoulder the lion share of the cost, with liability for the generics as well. Id. at *15. Another is a recognition that the FDA, not the courts, is better suited to handling the relationship between brands and generics. Id. at *16. And third, liability is usually about who has control. Brand manufacturers have no control over whether the generic manufacturer complies with FDA regulations, conforms the product to its design, or any other aspect of the manufacture and distribution of the generic product. Id. at *17. These policy considerations outweigh any foreseeability.
Finally, plaintiff tried to argue that the proposed FDA amendments regarding generic drugs should be viewed as a policy change leaning toward the adoption of innovator liability. Id. at *21. It is actually closer to the opposite. If anything, the amendments may possibly lead to opening up generic manufacturer liability. It certainly doesn’t do anything to extend brand manufacturer liability.
It may not be breaking news, but it’s still good news.